Applicator for catamenial device having improved gripper end

ABSTRACT

The present invention relates to applicators for inserting objects into body cavities, and to methods for making the same. The applicators are particularly useful for inserting catamenial and prophylactic devices into a vaginal canal. The applicators comprise a tubular insertion member and a retrofitted gripping member. The gripping member has an outer diameter greater than that of the insertion member. An interface is created due to this size differential, which provides a visual or tactile cue of applicator insertion depth, and thereafter object positioning within the body cavity. The gripping member comprises at least one raised area on its outwardly disposed surface, providing resistance to movement of the user&#39;s manual digit in response to longitudinal forces on the insertion member.  
     Longitudinal forces are created during both the insertion step of use, as well as the expulsion step delivering the contained object from the insertion member into the body cavity.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application is a continuation-in-part of U.S. Ser. No.09/602,950, filed on Jun. 23, 2000, entitled “Applicator for CatamenialDevice Having Improved Gripper End” (Attorney Docket PPC-732), thedisclosure of which is herein incorporated by reference.

FIELD OF THE INVENTION

[0002] The present invention provides an applicator comprising a tubularinsertion member and a retrofitted gripping member. The applicator isparticularly useful for delivering a catamenial device into the vaginalcanal, such as a tampon or menstrual collection cup.

BACKGROUND OF THE INVENTION

[0003] Applicators for inserting and expelling objects into a bodycavity typically comprise a tubular insertion member having an insertionend and a trailing end opposite thereof, and an expulsion memberslideable within the tubular insertion member. The trailing endgenerally incorporates features to allow a user to more or less securelyhold the applicator during use—inserting the applicator into a bodycavity, expelling a substantially enclosed object contained by theapplicator, and withdrawing the applicator from the body. Unfortunately,many applicators known in the art comprise a gripping section thatexhibits a weakness during at least one of the three above-identifiedsteps of using the applicator.

[0004] Voss, U.S. Pat. No. 4,361,150, and Sartinoranont, U.S. Pat. No.4,447,222, incorporates projections, such as a ring, at the trailing endof the applicator member.

[0005] These projections provide resistance to rearward finger slippageduring the expulsion step of using an applicator, and they may help theuser to remove the applicator from her body.

[0006] Whitehead, U.S. Pat. No. 4,508,531, reduces the diameter of theapplicator in the vicinity of the tubular insertion member trailing end.The reduced diameter creates a shoulder near the insertion end to resistfinger slippage toward the insertion end during the insertion step.

[0007] Both of these approaches suffer from providing resistance tofinger slippage in only one direction.

[0008] Efforts to provide resistance in two directions, as disclosed inthe art, suffer from shortcomings as well.

[0009] First, Voss, U.S. Pat. No. 3,575,169, increases the friction onthe trailing end of the tubular insertion member by coating it withpulverized stone or sand. This may be especially helpful as applicatormanufacturers are moving toward the use of higher gloss surfaces, whichare purported to aid in ease of applicator insertion into a body cavity.

[0010] Second, Hagerty, U.S. Pat. No. 5,709,652, employs a plurality offinger-accepting apertures in the applicator to provide relativelyabrupt, finger-accepting edges. These edges frictionally resist movementof a user's finger in response to longitudinal forces on the device.Although a useful contribution to the art, the finger-accepting edgesdisclosed by Hagerty, are generally limited to the wall thickness of theapplicator.

[0011] Finally, Suzuki et al., U.S. Pat. No. 4,921,474, discloses asanitary tampon applicator comprising a plastic outer sleeve having adiameter-reduced section along a length adjacent its rear end so as toform an annular shoulder, and a annular rib at its rear open end. Thisdevice has two or more physical restraints as a means for the user tohold the applicator securely during all of the steps of use. It isnoteworthy that the Suzuki applicator is limited to a “plastic” outersleeve. One skilled in the art would recognize that it would bedifficult to form similar physical restraints (shoulder and rib) on apaperboard applicator. Plastic applicators incorporating such designfeatures traditionally employ sophisticated molds and processes ininjection molding operations, e.g., comprising split cores and/or sideslides. The resulting mold designs and processing steps can addsignificant costs to the final product.

[0012] Accordingly, what is needed, is an applicator that can bemanufactured by low-cost, high-speed equipment and retrofitted with asuperior gripping member that has features to help during insertion ofthe applicator into a body cavity, expulsion of a contained object, andwithdrawal of the applicator from the body.

SUMMARY OF THE INVENTION

[0013] The present invention relates to applicators for insertingobjects into body cavities, and to methods for making the same. Theapplicators are particularly useful for inserting catamenial andprophylactic devices into a vaginal canal. The applicators comprise atubular insertion member and a retrofitted gripping member affixed tothe tubular insertion member.

[0014] The tubular insertion member has an insertion end, an oppositelydisposed trailing end, and a trailing end outer diameter. The grippingmember extends beyond the trailing end in a direction away from theinsertion end.

[0015] The maximum outer diameter of the gripping member greater thanthe maximum coplanar trailing end outer diameter. Preferably, a minimumouter diameter of the gripping member is at least equal to the maximumcoplanar trailing end outer diameter. Finally, the gripping member has aleading end directed toward the insertion end of the tubular insertionmember and a trailing edge disposed distal the insertion end of thetubular insertion member, as assembled.

[0016] The gripping member comprises at least one raised area on itsoutwardly disposed surface. This raised area resists movement of theuser's manual digit in response to longitudinal forces on the insertionmember.

[0017] Longitudinal forces are created during both the insertion step ofuse, as well as the expulsion step delivering the contained object fromthe insertion member into the body cavity.

[0018] The present invention also provides methods for makingapplicators having retrofitted gripping members, including affixinggripping members as disclosed above, to the trailing end of a tubularinsertion member.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019]FIG. 1 is a perspective view of an applicator having a tubularinsertion end, a trailing end opposite thereof, and a tubular expulsionmember slideably fitted within the trailing end.

[0020]FIG. 2 is a perspective view of the applicator in FIG. 1 having agripping member retrofitted onto the trailing end of the tubularinsertion member.

[0021]FIG. 3 is a perspective view of a preferred gripping member.

[0022]FIG. 4 is a cross-sectional view of the applicator in FIG. 2.

[0023]FIG. 5 is an end view of the gripping member shown in FIG. 3,depicting a plurality of the protuberances and stops.

[0024]FIG. 6 is a cross-sectional view taken from FIG. 5.

[0025]FIG. 7 is a side view of a gripping member having two distallylocated flanges.

[0026]FIG. 8 is a perspective view of a second preferred gripping memberemploying optional internal flexible arms.

[0027]FIG. 9 is a cross-sectional view of the gripping member in FIG. 8retrofitted onto a tubular insertion member.

[0028]FIG. 10 is a perspective view of a third preferred gripping membercomprising an annular ring having flexible arms extending therefrom.

[0029]FIG. 11 is a side view of the gripping member in FIG. 10retrofitted onto a tubular insertion member.

[0030]FIG. 12 is a diagram of steps included in a method ofmanufacturing applicators provided by the present invention.

[0031]FIG. 13 is a diagram of steps included in a second method ofmanufacturing applicators provided by the present invention.

[0032]FIG. 14 is a side elevation of an alternative embodiment of thepresent invention, prior to and after assembly.

[0033]FIG. 15 is a cross-sectional view of an alternative embodiment ofa gripping member retrofitted onto a tubular insertion member.

DETAILED DESCRIPTION OF THE INVENTION AND THE PREFERRED EMBODIMENTS

[0034] As used herein the specification and the claims, the term“diameter” (and variants thereof) relates to a chord passing through thecenter of a figure or body, i.e., the length of a straight line throughthe center of an object.

[0035] As used herein the specification and the claims, the phrase“coplanar diameter” (and variants thereof) relates to diameters of twoor more elements having the same longitudinal axis, the diametersextending along parallel lines perpendicular to and in the plane of thelongitudinal axis.

[0036] As used herein the specification and the claims, the phrase“coincident diameter” (and variants thereof) relates to diameters of twoor more elements extending through the same point and along the sameline or plane.

[0037] Thus, a pair of coplanar diameters that extend through the samepoint are coincident.

[0038] The present invention provides an applicator comprising a tubularinsertion member and a retrofitted, superior gripping member, employingdesign features that aid in inserting the applicator into a body cavity,expelling a contained object, and withdrawing the applicator from thebody. Manufacturing the gripping member separately provides numerousadvantages, some of which will be discussed below.

[0039] One significant advantage is the versatility of materials andprocesses available for manufacturing the tubular insertion andexpulsion members. Paperboard products appeal to both the manufacturerand the consumer, derived from factors such as ease of manufacture, costof manufacture, purchase cost, environmental benefits, and flushabilityconvenience. However, their features intended to aid the consumer inhandling the product during use have been limited. Embossed rings andfinger-accepting apertures are typically confined to the gauge of thepaperboard (or combined layers) used. A superior gripping member,manufactured separately, can be retrofitted onto a paperboard tubularinsertion member, without significantly eliminating any of the notedappeal.

[0040] Insertion and expulsion members are also manufactured fromplastic. Generally, commercially available products are made frompolyolefins, such as polyethylene, and at least the tubular insertionmembers of these products are formed through an injection moldingprocess. This process is used to enable the manufacturer to balance keycharacteristics of the tubular insertion member. Molding inserts andcores are machined to form a tapered product in which the wall thicknessin the gripping region is relatively thick to maintain structuralstability during the insertion and expulsion steps of use. While thethickness in the insertion end is minimized to provide flexibility andlow expulsion force. Injection molding also enables the manufacturer tomake uniquely shaped (e.g., curved) tubular insertion members as well asto make gripping features that would be difficult or impossible toachieve using alternative processes. However, there are lesssophisticated and less expensive polymer forming techniques, such asextrusion and blow molding, that could be employed if it is notnecessary to incorporate complex features into the tubular insertionmember, itself. Instead, the more complex features could be separatelyformed and retrofitted onto such an inexpensively manufactured tubularinsertion member.

[0041] In this manner, the gripping member itself can provide asubstantial portion of the structural stability necessary for insertingand expelling objects into body cavities. Therefore, a minimum amount ofpaperboard or an extremely thin-walled polymeric tube may be used inconjunction with the gripping member as a complete and useful system.This approach can reduce the cost of manufacture and eliminate thelikelihood that the applicator may collapse during use.

[0042] A second advantage offered by separate component manufacturing isrealized through the option of using state of the art high-speedequipment, such as disclosed in Hinzmann, U.S. Pat. No. 4,755,164, thedisclosure of which is herein incorporated by reference, andcommercially available from Hauni Richmond, Inc. of Richmond, Va.Hinzmann employs reservoir systems that accumulate applicator componentsbetween major steps of manipulation and assembly. Applicators with anysignificant projections extending from their outer surfaces will notstack neatly (parallel) in the reservoir systems, thereby reducing theefficiency of space and transfer. Such products may also create processdowntime due to applicators being “hung up” in the accumulators. Thereservoir systems provide efficiency in multi-component manufacturing bymaintaining continuous overall production even during downtime of anupstream piece of equipment. Manufacture of the tubular insertionmember, expulsion member, and e.g., tampons, as well as componentassembly, can take place with the gripping member retrofitted as a finalstep prior to packaging.

[0043] One technique that can be employed for affixing a separatelymanufactured gripping member to a tubular insertion member is to pressthe gripping member onto the outer surface of one end. This techniquenecessitates that the gripping member's smallest outer diameter will begreater than the coincident outer diameter of the tubular insertionmember it is combined with. This size differential creates aninterference fit between the element and may also provide a visual or atactile cue of applicator insertion depth, and thereafter objectpositioning within the body cavity. Greater control and handling is alsoprovided with a gripping member having a greater diameter than that ofthe tubular insertion member. Applicators known in the art havingreduced diameter gripping regions, do so by “necking down” a portion ofthe tubular insertion member (see for example Huffman, U.S. Pat. No.4,573,964). As the gripping area is reduced, so is the amount of controlby the user. Moreover, an expulsion member used with such an applicatorwill necessarily become small and more difficult to use. Consumers havevoiced dislikes associated with small expulsion members.

[0044] Another, related technique is to press a fitting extending fromthe gripping member into the end of the tubular insertion member. Thistechnique necessitates that the fitting extending from an inner portionof the gripping member has an outer diameter that creates aninterference with the inner diameter of the tubular insertion member itis combined with.

[0045] Preferred embodiments of the present invention are illustrated inthe figures and corresponding description, wherein like elements arelabeled with like numerals. As shown in FIG. 1, applicator 1 comprises atubular insertion member 10 having an insertion end 11, an opposingtrailing end 12, and a tubular expulsion member 20 slideably fittedwithin the trailing end 12.

[0046] The insertion end 11 is preferably substantially closed prior toexpulsion of an object contained therein. As can be seen in FIG. 1, onetechnique for substantially closing the insertion end 11 is by employinga plurality of inwardly curved petals 13. The petals will flex and/orhinge to an open position upon expelling objects contained by thetubular insertion member 10. The number of petals generally ranges fromabout 4 to about 6. An alternative technique is a pleating process isdisclosed in Neilsen et al., U.S. Pat. No. 5,782,793. Alternatively, theinsertion end may be more or less open, that is the diameter along thelength of the tubular insertion member is substantially equivalent tothe diameter of the insertion end. Proctor & Gamble, of Cincinnati,Ohio, currently offers for sale an open-ended tampon applicator underthe trade name TAMPAX brand flushable applicator tampons.

[0047] The tubular insertion and expulsion members of the presentinvention can be made from numerous materials generally known to thoseof ordinary skill in the art, such as plastic (polymers) and paperboard.Plastic applicator members may comprise conventional polymers, such aspolyolefins, or be of more sophisticated polymers and polymer blendsformulated to provide features such as biodegradability and/or waterdispersibility. A representative, non-limiting list of polymers,includes polyolefins, such as polyethylene, and polypropylene;polystyrene, polyvinyl alcohol, polylactic acid, poly(3-hydroxybutyricacid), and combinations thereof. Examples of applicators that aredesigned to be dispersible or biodegradable are disclosed in Herring,U.S. Pat. No. 5,002,526 and Assenheimer-Downs, U.S. Pat. No. 5,782,794relating to applicators made from polyvinyl alcohol based compositions,Billmers, U.S. Pat. No. 5,350,354 relating to applicators made fromstarch based compositions, and Webb, U.S. Pat. No. 4,900,299 relating toapplicators made from poly(3-hydroxybutyric acid) based compositions.Plastic members may be made by injection molding, blow molding,extrusion and the like.

[0048] Paperboard tubular and expulsion members may be constructed froma single layer of paperboard material, lo or from a plurality oflaminated layers. Useful paperboard stock for the formation of themembers includes, without limitation, paperboard, cardboard, cup stock,paper, and the like. The following non-limiting processes may be usedfor making paperboard applicator components: spiral winding as disclosedin Campion et al., U.S. Pat. No. 5,346,468, convolute winding asdisclosed in Whitehead, U.S. Pat. No. 4,508,531, and forming a sheetaround a mandrel and then sealing an overlapped seam as disclosed inHinzmann, U.S. Pat. No. 4,755,164.

[0049] Paperboard members may include one or more surface layers, whichmay be useful to increase the comfort and ease of insertion and withdrawof the applicator. The surface layers may be in the form of laminatedfilms, cured coatings, and the like. An example of such a surface layeris disclosed in Blanchard, U.S. Pat. No. 6,171,426 (B1). Arepresentative, non-limiting list of useful materials to be used as thesurface layers includes, waxes, cellophane, polyolefins, polyesters,epoxies, and the like. The surface layers may also include thermalstabilizers, pigments, fragrances, surfactants, antimicrobial agents,medicaments, and the like.

[0050] There are many techniques known for applying the surface layers.A representative, non-limiting list of such techniques includesspraying, extruding, slot coating, brushing, transfer coating, and thelike. Additional processing steps may be required to cure the surfacetreatments to a useable form other than simple air curing, such asapplying irradiation or other forms of energy.

[0051] Typical dimensions for each of the tubular insertion andexpulsion members include a length of from about 50 to about 100millimeters, a diameter of from about 8 to about 20 millimeters, and athickness of from about 0.1 to about 0.6 millimeters. Preferably theinsertion and expulsion members are cylindrical tubes that aresubstantially straight along their lengths. They may however, be ofalternative geometry, such as square, elliptical, or triangular incross-section. Additionally, the tubular members may be curvilinearalong their length to improve comfort and manipulation of the applicatorduring insertion and withdraw from a body cavity. An example of curvedapplicator components can be seen in Paul et al., U.S. Pat. No.5,158,535.

[0052] Referring to FIG. 2 which illustrates a preferred embodiment,applicator 1 further comprises a gripping member 30, which ismanufactured separately from the insertion and expulsion members andthereafter affixed, preferably immovably, to at least a portion of thetrailing end of the tubular insertion member.

[0053] FIGS. 2-6 depict this preferred embodiment of the gripping member30, having a minimum outer diameter 31, a length “L”, and anintermediate area 40 disposed between two longitudinally separatedraised areas 41 a and 41 b. The gripping member has a leading end 45directed toward the insertion end of the tubular insertion member 10 anda trailing edge 32 disposed distal the insertion end of the tubularinsertion member, as assembled. The curvilinear transition between theintermediate area and the two raised areas preferably forms a“saddle-shaped” profile. This profile provides comfort and control bycorresponding to the natural curvature of a user's manual digits (thumband fingers). A distally located optional flange 42 is also depicted inthe figures. The flange 42 provides a structure for the user to grasp towithdraw the insertion member from a body cavity.

[0054] The gripping member length “L” is at least about 5 millimeters,and preferably at least about 10 millimeters. Such a length of thegripping member allows the user to grasp the gripping member, ratherthan placing her manual digits (e.g., fingers) on either side of it. Thegripping member should be of sufficient length, such that the utility ofdesign features employed to provide resistance to movement of the user'sfingers, is not compromised. For example, if the length of the grippingmember is capable of accepting the user's manual digits, especiallybetween longitudinally separated raised areas, it becomes less likelythat the user's fingers, etc., would span the distance between theseraised areas and lose the benefits of the present invention. Such adistance “D” is preferably at least about 0.35 inches (about 9 mm), morepreferably about 0.4 to about 0.6 inches (about 10 mm to about 15 mm).

[0055] We have learned that consumers would like to have small diameterapplicators while not compromising absorbency. This improves comfortwhile inserting the device. However, as the diameter of the applicatordecreases, user control correspondingly decreases. In an effort toensure that the gripping member has sufficient area to grasp during use,especially with relatively small diameter insertion members, thegripping member preferably has a length to diameter ratio of at leastabout 0.5.

[0056] The inner surface of the gripping member may have features thatimprove its fixation to the tubular insertion member. For example, aseries of optional protuberances 44 are also shown in the figures. Thetubular insertion member may employ a cavity proximal its trailing end,such as an aperture 14 shown in FIG. 1, which is capable of receivingone or more of the protuberances 44. The cavity may be any generallyconcave feature that is capable of receiving the protuberances, examplesincluding embossed regions and apertures. The cross-sectional view inFIG. 4 illustrates the protuberances 44 residing in a portion of twoapertures 14 as taught in Hagerty, U.S. Pat. No. 5,709,652, thedisclosure of which is herein incorporated by reference. Theprotuberances may be designed such that they provide additionalresistance to separation of the gripping member from the tubularinsertion member. For example, the protuberances may be triangulated, orcomprise a barb, wherein an apex or barb is capable of pressing into asurface of the tubular insertion member. “Pressing into” may includecreating indentations, ruptures, gouges and the like.

[0057] Referring now to FIGS. 5 and 6, preferably the gripping memberhas from about 2 to about 12 protuberances, and more preferably from 3to 9. The protuberances have a height “H”. It may be helpful in someconstructions to relate the height of the projection to the thickness ofthe material forming the tubular insertion member, the manner ofattachment of the gripping member, and the relative outside diameter“Φ_(T)” of the tubular member trailing end and the inside diameter 31 ofthe gripping member. In a press fit attachment, the height “H” ispreferably at least about 0.0005 inches (about 0.01 mm), more preferablyat least about 0.001 inches (about 0.03 mm). In a mechanical latchattachment, the height “H” may be at least about 0.003 inches (about0.08 mm), more preferably, at least about 0.005 inches (about 0.1 mm),and most preferably about 0.01 to about 0.02 inches (about 0.3 to about0.5 mm). The protuberances may have an arc “S” of at least about 0.5degrees, preferably, in a mechanical latch attachment manner asdisclosed in e.g., FIGS. 3-7, an arc of about 3 to about 10 degrees, andmost preferably about 5 to about 7 degrees.

[0058] The gripping member 30 may optionally have at least one stop 50extending inwardly from a trailing edge 32, the edge of the grippingmember 30 that is the furthest from the insertion end 11 of the tubularinsertion member, as assembled. The stop is capable of maintaining thegripping member 30 at the trailing end 12 of the tubular insertionmember. A preferred embodiment has nine protuberances and three stops.

[0059] Additionally, FIGS. 5 and 6 illustrate the preferred out of phasepositional relationship of the protuberances 44 and the stops 50. Thispositioning provides the attractive option of using simpler injectionmolding processes and equipment.

[0060] The inner surface of the leading end 45 of the gripping member 30is preferably tapered from a relatively larger inner diameter at theleading end 45 to a relatively smaller inner diameter further into thegripping member 30. This increases the tolerances during assembly of thegripping member 30 and tubular insertion member 10, such as imperfectlyformed parts, misalignment, and the like.

[0061] While the FIGS. 2-6 show a gripping member 30 being affixed tothe tubular insertion member 10 overlying a portion of the insertionmember trailing end 12, the present invention may also employ a grippingmember 30′ that extends beyond the trailing end 12 in a direction awayfrom the insertion end 11. This may be achieved by a gripping member 30′that abuts the tubular insertion member trailing end 12, or that has afitting 43 that extends from an inner portion of the gripping member 30′toward the insertion end 11 of the tubular insertion member, asassembled, the leading end 45 of the gripping member 30′ and isinsertable into the trailing end 12 of the tubular insertion member.While a rearwardly extending gripping member 30′ may not require theprotuberances and stops in the manner described above, the embodimentsillustrated in FIGS. 14A and 15 incorporate protuberances. In thisaspect of the present invention, the maximum outer diameter “Φ_(G) max”is greater than the maximum coplanar trailing end outer diameter Φ_(T).Preferably, the minimum outer diameter “Φ_(G) min” of the grippingmember 30′ is at least equal to, and more preferably greater than, themaximum coplanar outer “Φ_(T) max” diameter of the tubular insertionmember trailing end 12.

[0062] The external physical features of a rearwardly extending grippingmember 30′ can be substantially the same as those described below forFIGS. 2-6. The tubular insertion member 10 acts as an outer sleeve overthe fitting 43 of the gripping member 30′ shown in FIG. 14A. Thus, in amanner similar to that shown above in FIGS. 2-6, the insertable grippingmember 30′ may incorporate a series of optional external protuberanceson the fitting 43 to improve the interference between the fitting 43 andthe tubular insertion member. The external protuberances may also bedesigned such that they provide additional resistance to separation ofthe fitting 43 from the tubular insertion member. These protuberancesare illustrated as a screw thread in FIG. 14A. As additional examples,the protuberances may be triangulated, or comprise a barb, wherein anapex or barb is capable of pressing into a surface of the tubularinsertion member. “Pressing into” may include creating indentations,ruptures, gouges and the like.

[0063] In the embodiment of FIGS. 14A & B, the fitting 43 extends fromthe leading end 45 of the gripping member.

[0064] This permits the use of a shorter tubular insertion member. Inthis embodiment, the fitting 43 is the first portion to engage thetubular insertion member 10 during assembly. Thus, it can beappropriately dimensioned to provide accurate and reliable fixation,including an appropriately tapered leading portion.

[0065] In contrast, the fitting 43 of the embodiment of FIG. 15 extendsfrom an inner portion of the gripping member 30′ proximal the trailingedge 32. In this embodiment, the leading end 45 of the gripping member30′ may be the portion to engage the tubular insertion member 10 duringassembly. Again, this element can be appropriately dimensioned toprovide accurate and reliable fixation, including an appropriatelytapered leading portion. In alternative embodiments of an inner fitting43 of FIG. 15, the leading portion of the fitting 43 could extend beyondthe leading end 45 of the rest of the gripping member 30′.

[0066] The interior dimensions of the extending gripping member 30′ canalso be tailored to the desired expulsion member. For example, a reduceddiameter expulsion member can save material costs of the applicatordevice.

[0067] It may also be easier to mold in a non-circular cross-section toallow orientation of an expulsion device than is currently possible in astandard paperboard tubular insertion member 10 or to otherwise improvethe interlocking of the expulsion member and tubular insertion member 10to prevent separation of the elements prior to use.

[0068] The gripping member 30 illustrated in FIGS. 2-6 has a curvilinearouter profile, generally “saddle” shaped, wherein the two raised areas41 a and 41 b are created by increasing the outer diameters towards therespective edges of the gripping member. An alternative gripping memberouter profile is depicted in FIG. 7, wherein the intermediate area 40has a flat profile yielding a constant outer diameter along the length,with the two raised areas 41 a and 41 b being formed by longitudinallyseparated flanges.

[0069] Additional outer profiles are possible, wherein the outer surfacehas at least one raised area that is capable of providing resistance tomovement of a user's manual digit in response to longitudinal forces onthe tubular insertion member. All of the figures depict the grippingmember having two raised areas separated by an intermediate area;however, a single raised area in conjunction with the other specifieddesign features may be sufficient for the utility of the presentinvention.

[0070] To improve the fixation of the gripping member to the tubularinsertion member, the gripping member may employ optional designfeatures that reside within the tubular insertion member trailing end12. Referring now to FIGS. 8 and 9, the gripping member 30 mayoptionally comprise one or more flexible arms 60 connected to its innersurface. The tubular insertion member 10 is fitted between the grippingmember inner surface and the flexible arms. In this embodiment,protuberances 44 reside on the flexible arms 60. The protuberances 44may be positioned within tubular insertion member apertures 14 as shownin FIG. 9. Alternatively, retrofitting to tubular insertion members notemploying apertures, the protuberances may incorporate design featurescapable of pressing into the tubular insertion member inner wall tooffer a more secure fit.

[0071] Another embodiment contemplated by the present invention is shownin FIG. 10. This embodiment minimizes both the cost and theenvironmental impact, due to a reduction in material required. Thegripping member 30 comprises an annular ring 70 and one or more flexiblearms 60 extending from an inner peripheral edge 71. The annular ringprovides resistance to rearward finger movement during the expulsionstep of using the applicator. Referring now to FIG. 11, to provideresistance in the opposite direction, a tubular insertion member 10 withapertures 14 proximal its trailing end is used, and protuberances 44,distally located on the flexible arms, are capable of extendingtherethrough.

[0072] Materials useful for the manufacture of the gripping memberinclude the following, non-limiting, representative materials:paperboard, paper, polymeric material, foam, and combinations thereof.Particularly useful polymeric materials include polyethylene,polypropylene, polystyrene, polyvinyl alcohol, polylactic acid,poly(3-hydroxybutyric acid), rubber and other elastomers, andcombinations thereof. The gripping member may optionally comprise anadditive, either through incorporation into the manufacturing materials,or added to the component through a subsequent processing step. Arepresentative, non-limiting list of additives includes fragrance,odor-neutralizing agents, bacteriostats, bacteriocides, andmoisturizers.

[0073] The gripping member can be made from any known techniques in theart. Injection molding and blow molding are two such methods useful formaking the gripping member from a polymer. Alternatively it can beconstructed with paperboard, wherein paper maché techniques are useful.Similar methods of manufacture to that of the tubular insertion membercan be used for making the gripping member from paperboard, whereinadditional steps are employed to form the along length diameterdifferential, such as rolling or folding the distal part of the firstand second section.

[0074] The gripping member outer surface may optionally comprisefriction-enhancing means, such as tacky coatings, etched patterns, andthe like. Such coatings and/or treatments may be evenly distributedabout the outer surface, or they may be restricted to or concentrated incertain, desired portions. The gripping member may be transparent oropaque, and it may be pigmented, as desired. Where a range of differingproducts is offered to the consumer, the gripping member can becolor-coded to indicate a particular product.

[0075] The present invention also provides methods for makingapplicators having retrofitted gripping members, such as those describedin relation to FIGS. 1-11. Generally the gripping member may be pressedonto a portion of the tubular insertion member and maintained in itsposition through the dimensions of each component. Preferably, designfeatures as described above such as protuberances, flexible arms, andstops are employed to help secure the gripping member to the tubularinsertion member. Beyond these features and for use with grippingmembers that do not overly the tubular insertion member, othermechanical features such as suction cups, chemical adhesives, andthermoplastic welding techniques may be used to affix the grippingmember or to enhance the fit between the gripping member and the tubularinsertion member. In particular, adhesives, such as chemical adhesivesand thermoplastic welding adhesives may be used to attach theabutting-type gripping members.

[0076] Typical applicators comprise both a tubular insertion member andan expulsion member slideably fitted therein into an opening at thetrailing end thereof. The process of assembling the two components, aswell as filling the tubular insertion member with an object can varysignificantly. Accordingly, the gripping member may be fitted onto aportion of the tubular insertion member prior or after assembly, prioror after filling, and fitted from either end of the tubular insertionmember. A detailed description of the preferred methods of making theapplicators of the present invention, including the steps and sequencingfollows.

[0077]FIG. 12 illustrates a method for making an applicator comprisingthe step of pressing preferred gripping member 30 onto a portion of thetubular insertion member trailing end 12 through the use of both lineardisplacement L1, and optional rotational displacement R1. The rotationaldisplacement can occur simultaneously with and/or after the lineardisplacement. The optional rotational displacement is at least about 0.5degrees, preferably at least about 5 degrees, and more preferably fromabout 10 to about 45 degrees.

[0078] Referring to FIG. 13, another method for making an intravaginalapplicator comprises the steps outlined below. A typical tubularinsertion member 10 is provided, having an insertion end 11 and atrailing end 12. Slideably fitted within an opening at the trailing end12 is a tubular expulsion member 20. An object such as a tampon (notshown) for insertion into a body cavity may be loaded in the tubularinsertion member from the trailing end prior to assembling the expulsionmember with the tubular insertion member, or alternatively be loadedfrom the insertion end. If the latter method is used, then any closingof the insertion end will take place thereafter, such as through apost-doming process.

[0079] A gripping member 30 is provided and coaxially aligned with theinsertion and expulsion members. The tubular insertion member is clampedwith a first clamping mechanism 80, and the gripping member is clampedwith a second clamping mechanism 81. Useful clamping or holdingmechanisms will be recognized by one ordinarily skilled in the art. Forexample, a two-sided clamp comprising a surface capable of conforming tothe outer geometry of the insertion and gripping members can be used. Anoptional internal stabilizing tool 90 is passed through the grippingmember and into a portion of the expulsion member. A displacement tool91 may engage the gripping member, and the second clamping mechanism maybe retracted. In a preferred embodiment illustrated in FIG. 13, theinternal stabilizing tool 90 may be held within the displacement tool 91in a telescopic arrangement. Through linear motion L2 of thedisplacement tool, the gripping member is advanced over the expulsionmember and onto (or into) at least a portion of the tubular insertionmember trailing end 12.

[0080] Lastly, the displacement tool, the optional internal stabilizingtool, and the first clamping member are all retracted, thereby freeingthe assembled applicator 1 for any further processing steps. Thesequencing of the steps may be altered to some degree without departingfrom the spirit and scope of the present invention.

[0081] Beyond those steps described above, additional procedures may beincluded in an assembly process. First, the step of advancing thegripping member onto the tubular insertion member trailing end 12 maycomprise both linear L2 and rotational displacement R2.

[0082] To accomplish this optional step, the displacement tool comprisesat least one prong 92 capable of juxtaposition with an at least one stop(shown as element 50 in FIGS. 5 and 6) extending inwardly from a bottomedge of the gripping member. Rotation of the displacement tool will thencorrespond to rotation of the gripping member.

[0083] Second, because the gripping member may employ protuberancesextending from its surface, the gripping member may be furthermanipulated to take advantage of these protuberances. For example, theprotuberances preferably press into the outer surface of the insertionmember to create indentations or “tracks” as the gripping member ispressed on. In an effort to maximize the utility of the protuberances,the gripping member may be rotated, labeled as rotational displacementR2, once it has completed its linear transition onto the tubularinsertion member is completed. The minimum rotational displacementrequired, preferably, is an amount slightly greater than the arc lengthof the protuberances. An upper range of rotational displacement will beapparent as multiple protuberances are used, that is, the displacementshould not be to the extent of removing a protuberance from one trackand placing it into another. When tubular insertion members compriseapertures proximate their trailing end, the rotational displacement willalso help to align the protuberances with those apertures.

[0084] Finally, another method contemplated by the present inventionincludes connecting multiple components together in a manner tocollectively form a gripping member circumscribing the trailing end ofthe tubular insertion member. This may be desirable, because toinjection mold this part as a single component, a mold having sideaction (side slides) would usually be used.

[0085] This side action increases the cycle times and decreases theamount of parts per mold area, both of which increase the costs perpart.

[0086] An example of a multicomponent gripping member could be dividingthe gripping member illustrated in FIGS. 2-6 into two separate ringsseparable, e.g., at the diameter line indicated as 31 in FIG. 6. Therings may employ coupling design features, such as mating male andfemale elements that are capable of fitting together to affix thegripping member to the tubular insertion member.

[0087] An alternative design may separate the gripping member into twoor more elements that could “clamp” the tubular insertion member. Such agripping member could be separated into two halves defined by a planeextending from line “L” in FIG. 3.

[0088] An advantage, when using injection molding processes formanufacture, provided by the concept of manufacturing multicomponentgripping members allows sophisticated design features to be includedwithout the necessity of sophisticated molds. The multicomponentgripping members can be molded in more economical single action molds.

[0089] The applicator of the present invention can be used for thedelivery of intravaginal objects, such as tampons, menstrual collectiondevices, and contraceptives. Further, the applicator can be used fordelivery of various other materials including, medicaments,moisturizers, vitamins and minerals, spermicides, and odor controllingagents. These materials may be in the form of solids, creams, foams,gels, and the like.

[0090] The applicators can be packaged with other non-like or likeproducts, and used as a system of products to satisfy individualconsumer needs. In particular, the applicators can be packaged withexternally worn or used absorbent products, such as a sanitary napkins,pantiliners, and interlabial pads.

[0091] The specification and embodiments above are presented to aid inthe complete and non-limiting understanding of the invention disclosedherein. Since many variations and embodiments of the invention can bemade without departing from its spirit and scope, the invention residesin the claims hereinafter appended.

What is claimed is:
 1. An applicator for inserting an object into a bodycavity, comprising: a) a tubular insertion member having an insertionend, an oppositely disposed trailing end and a trailing end outerdiameter; and b) a gripping member affixed to the tubular insertionmember trailing end and extending beyond the trailing end in a directionaway from the insertion end, having a maximum outer diameter greaterthan the maximum coplanar trailing end outer diameter, a minimum outerdiameter that is at least equal to the maximum coplanar trailing endouter diameter, and a leading end directed toward the insertion end ofthe tubular insertion member and a trailing edge disposed distal theinsertion end of the tubular insertion member, as assembled
 2. Theapplicator of claim 1 wherein the gripping member has two raised areasseparated longitudinally by an intermediate area having an outerdiameter less than that of each of the raised areas.
 3. The applicatorof claim 2 wherein the gripping member comprises curvilinear transitionsbetween the intermediate area and the two raised areas.
 4. Theapplicator of claim 1 wherein the gripping member abuts the trailing endof the tubular insertion member.
 5. The applicator of claim 1 whereinthe gripping member comprises a fitting arranged and configured toextend from an inner portion of the gripping member toward the insertionend of the tubular insertion member, as assembled.
 6. The applicator ofclaim 5 wherein the fitting extends from the leading end of the grippingmember.
 7. The applicator of claim 1 wherein the gripping membercomprises at least one feature capable of encircling a user's fingerduring use.
 8. A method for making an applicator, comprising the stepsof: a) providing a tubular insertion member having a trailing end and atrailing end outer diameter; b) affixing a gripping member to thetrailing end, the gripping member having a maximum outer diametergreater than the maximum coplanar trailing end outer diameter, a minimumouter diameter that is at least equal to the maximum coplanar trailingend outer diameter and a length to diameter ratio of at least 0.5. 9.The method of claim 8 wherein the tubular insertion member comprisespaperboard.
 10. The method of claim 8 wherein the step of affixing thegripping member comprises advancing the gripping member toward androtating the gripping member with respect to the tubular insertionmember.